Complete Response Letters, NDA Filings Proposed for FDA Transparency

摘要

The FDA should disclose whenever an NDA, ANDA or BLA is submitted or withdrawn by a drugmaker, as well as detailed information about the company and the proposed product, an agency task force has recommended.rnThe proposal, along with 20 others, was made by the agency's Transparency Task Force Wednesday as the second phase of its transparency initiative, designed to shed light on the FDA's operations and decisionmaking processes. The agency is seeking comments from stakeholders on the report by July 19.